Recall of Device Recall MEVION S250

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Mevion Medical Systems, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, radiation therapy, charged-particle, medical - Product Code LHN
  • Reason
    Possibility of gantry motion with aperture or compensator only partially inserted. an aperture may fall out during gantry motion. it is possible that it can hit a patient and cause traumatic injury or death.
  • Action
    Customer notification letters were sent to customers on March 15, 2016, by certified mail, return receipt requested, as well as by email. The letter explains the problem, description of potential harm, and the cause containment, and mitigation. The cause of the malfunctioning sensors was discovered to be a non-conforming limit switch assembly. A Mevion Field Service Engineer will immediately inspect all such parts in the field for similar non-conformance, and replace those parts if necessary. In addition, a new periodic preventive maintenance check will be performed to individually test each of the redundant sensors at all sites. In the interim period, on a daily basis, until the inspection, repair, and the preventive maintenance check is completed at any site, Mevion Field Service will check that the Applicator Door interlock sensors are working properly. Mevion will also update the inspection procedure for incoming parts to ensure that any non-conformance is identified early in the manufacturing process.


  • Model / Serial
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    US nationwide distribution to MO, OK, FL, and NJ.
  • Product Description
    MEVION S250 for Proton Radiation Therapy
  • Manufacturer


  • Manufacturer Address
    Mevion Medical Systems, Inc., 300 Foster Street, Littleton MA 01460-2017
  • Manufacturer Parent Company (2017)
  • Source